BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2910426 · Received January 11, 2013

    Report

    Report Number
    3004209178-2013-00467
    Event Type
    Injury
    Date Received
    January 11, 2013
    Report Date
    December 18, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) REVEALED THE FOLLOWING: THERE WERE NO ANOMALIES FOUND. THE INS WAS RECEIVED WITH NO TELEMETRY. ACCORDING TO THE TRACE REPORT OBTAINED FROM THE INS, THE TOTAL RECHARGE COUNT IS 252. THE LAST RECORDED RECHARGE SESSION DONE WHILE THE DEVICE WAS IMPLANTED WAS A PHYSICIAN MODE RECHARGE THAT RESET THE INS DATE TO THE DEFAULT DATE (B)(6) 2000. THE DEVICE WAS RECHARGED FOR 57 MINUTES FROM 2.055V TO 2.985V. PRIOR TO THE PMR THE DEVICE WAS RECHARGED ON (B)(6) 2011 FOR 45 MINUTES. THE BATTERY CHARGED FROM 3.815V TO 3.900V. THE PARAMETER TREND DIAGNOSTIC SECTION OF THE TRACE REPORT SHOWS PATIENT USAGE AFTER THIS RECHARGE SESSION. THE BATTERY DISCHARGED TO THE LOCK MODE ON (B)(6) 2012. DURING ANALYSIS, A NORMAL RECHARGE WAS STARTED MANUALLY AFTER A PHYSICIAN MODE RECHARGE AT BODY TEMPERATURE WITH A 1CM SPACER BETWEEN THE INS AND RECHARGE ANTENNA. THE RECHARGER HAD FULL COUPLING AND THE INS RECHARGED FOR 6 HOURS AND 58 MINUTES FROM 1.985V TO 3.860V.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS USED FOR AN OFF LABEL INDICATION. THE THERAPY THE DEVICE WAS USED FOR, WAS MRU. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 37092, LOT# 243240001,IMPLANTED: (B)(6) 2010, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V444283, IMPLANTED: (B)(6) 2010. PRODUCT TYPE: LEAD. PRODUCT ID: 3387S-40, LOT# V444283, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE BATTERY HAD BEEN TURNED OFF IN (B)(6) WITH 50% OF THE BATTERY CHARGE LEFT. AFTER THE FIRST PHYSICIAN MODE RECHARGE TOOK PLACE INSTEAD OF SEEING THE NORMAL RECHARGING SCREEN, THE MANUFACTURER REPRESENTATIVE SAW A SCREEN WITH A LITTLE ¿I¿ IN THE CORNER WITH A PICTURE OF AN ANTENNA HEAD APPEARED INDICATING A NEED TO REPOSITION THE ANTENNA.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE REPLACEMENT SURGERY WENT FINE AND THE PATIENT WAS RECEIVING EFFECTIVE THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WERE TELEMETRY ISSUES WITH THE IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS UNCLEAR IF THE DEVICE WAS IN A STATE OF DISCHARGE OR OVERDISCHARGE. TWO DAYS LATER, IT WAS REPORTED THE INS HAD "POTENTIALLY BEEN IN OVERDISCHARGE SINCE (B)(6) 2012." IT WAS INDICATED THAT ONE PHYSICIAN RECHARGE MODE (PRM) HAD BEEN PERFORMED; HOWEVER, THE NORMAL RECHARGE SCREEN DID NOT COME BACK. IT WAS ALSO STATED THE INS HAD BEEN IN OVERDISCHARGE FOR ¿ABOUT 6 MONTHS.¿ IT WAS UNCLEAR EXACTLY HOW LONG THE INS WAS IN OVERDISCHARGE FOR. A SECOND PRM WAS COMPLETED, AND THE BATTERY STILL DID NOT COME BACK TO A CHARGING STATE. IT WAS STATED BY THE MANUFACTURER REPRESENTATIVE THAT THE HEALTHCARE PROVIDER (HCP) ADVISED THE PATIENT TO TURN THE DEEP BRAIN STIMULATION (DBS) OFF FOR AN EXTENDED TIME. THIS WAS MEANT TO "TROUBLESHOOT THE EFFECT OF THE DBS WITH STIMULATION AND WITHOUT." A WEEK LATER, IT WAS STATED THE PATIENT HAD A WORSENING OF SYMPTOMS DURING THE TIME THE INS WAS IN OVERDISCHARGE. IT WAS FURTHER STATED BY THE MANUFACTURER REPRESENTATIVE, THAT THE HCP "WANTED TO TRY BOTOX," AS THE PATIENT HAS DYSTONIA. IT WAS NOTED THAT SIX ATTEMPTS WERE MADE TO RESET THE INS, WITHOUT SUCCESS. IT WAS INDICATED THE PATIENT "WAS UNWILLING TO TRY ANYMORE." THE PATIENT WAS SCHEDULED TO HAVE THE INS EXPLANTED AND REPLACED WITH A NON-RECHARGEABLE INS ON (B)(6) 2013. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE DEVICE COULD NOT BE RECOVERED FROM OVERDISCHARGE DESPITE 6 ATTEMPTS. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18042 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT PUERTO RICO OPERATIONS CO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention